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Risperdal
Robert A. Mosier
Sanders Phillips Grossman, LLC
2860 Michelle Drive, Ste 220
Irvine, CA 92606
Rmosier@thesandersfirm.com
949-233-7002 Cell
Offices in CA, NY, WA, PR

Risperdal Basics
SANDERS PHILLIPS GROSSMAN, LLC.

What is Risperdal?
? It is a very powerful antipsychotic developed by
Janssen Pharmaceuticals to treat schizophrenia in
adults
? It works by blocking dopamine receptors in the brain
(dopamine antagonist)
? However, it also has a serious side effect 每 by
blocking dopamine, it causes prolactin to spike out of
control (rises more than 10 times normal limits in
first 1-3 hours) and prolactin remains elevated while
on the drug
3SANDERS PHILLIPS GROSSMAN, LLC.

What is Prolactin?
? Prolactin is the hormone responsible for breast
growth and lactation in pregnant women.
? Breast growth and lactation are wonderful for
pregnant women and their newborns.
? However it is psychologically and physically damaging
to young boys and men . . . .

So why are we here?
? Because Janssen illegally marketed and
sold its powerful antipsychotic drug,
Risperdal, to one of the most vulnerable
segments of our society 每 our children 每
and hid this disfiguring side effect
causing a generation of young boys and
men to grow female breasts.
(gynecomastia).

So why was Janssen illegally pushing this powerful
antipsychotic on our children?
Because Janssen wanted more, a lot more＃

More market share,
More sales,
More profits.

Janssen＊s illegal marketing scheme
worked
By 2008, Risperdal was a Billion Dollar
Blockbuster drug.
? Janssen sold $3.4 Billion of Risperdal in 2008.
? Risperdal was Janssen＊s #1 selling drug.
? It was drug giant Johnson & Johnson＊s #2
selling drug worldwide.

But then they got caught＃.
? Because of J&J＊s illegal marketing of
Risperdal, Janssen pled guilty to criminal
charges of off-label marketing 每 coupled
with a contemporaneous False Claims Act
action brought by the United States, and
paid $2.2 Billion in criminal and civil
fines 每 the third largest in US History.

11
Risperdal Label
History

Risperdal Label and Approvals
? 1993 (Adult 每 psychotic disorder/schizophrenia)
? 2006 (Child & Adolescent 每 Autism (Irritability))
? 2007 (Child & Adolescent 每 Schizophrenia &
Mania Associated with BiPolar Disorder)
? 2008 (Generic 每 Patriot)

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1993 每 2006 Adult Label

14
1993 每 2006 Adult Only

18
2006/2007 Label
C&A Indication

2006 Risperdal Prescribing Information (PI) @ 11
※INDICATIONS AND USAGE§

※USE IN SPECIFIC POPULATIONS§

22
2007 Label

Approved Pediatric Indications- Summary
RISPERDAL
? 1993- October 2006 每 NO PEDIATRIC INDICATION
? October 2006 每 Irritability associated with autistic disorder
? December 2007 每 Adolescent Schizophrenia and Mania
Associated with Bi-Polar disorder.
? NEVER approved for ADD, ADHD, OCD, Tourette, Depression,
Conduct Disorder, etc.

Attempts to obtain C&A Indications
and Off-Label Marketing prior to
2006

1993 每 Risperdal Approved for Adults
By 1996, Janssen figured out it was missing
a huge untapped and profitable market..
The child and adolescent market worth
hundreds of millions of dollars
So they tried to get FDA approval＃

1996 每 FDA - Denied
? ※you have not identified any pediatric indications for
which you believe Risperdal could be approved and
you have provided no data from adequate and well-
controlled trials to support such approvals＃ To
permit the inclusion of the proposed vague
references to the safety and effectiveness of
Risperdal in pediatric patients and the nonspecific
cautionary advice about how to prescribe Risperdal
for the unspecified target indication would only
serve to promote the use of this drug in pediatric
patients without any justification.§

Janssen did not care . . . They wanted
more.
They knew the child and adolescent
market was an untapped gold mine.
So they hatched a plan.

First, they tried to get approval from
the FDA . . . again.

March 2000 每 Denied - Again
※main concern is that RISPERDAL or
any other product would be used as a
chemical straight jacket.§

But they wanted more
So they decided self help was in order
and turned to the Johnson & Johnson
marketing machine 每 their sales force.

2001 Business Plan Focused on
Pediatrics
? Concluded that the fastest growing
market for Risperdal was pediatrics (19
and under)
? Use of Risperdal was ※exploding§ at a
growth rate of 17%, for a total market
share of $340M per year

2001 Business Plan - Call to Action
? Key Business goal was to grow and protect share in the
child/adolescent market.
? Instructed sales reps to call on child psychiatrists and
children＊s mental health facilities
? Instructed sales reps to market Risperdal as effective for
ADHD, OCD and autism
? Sponsored advisory boards with child psychiatrists
? Sponsored Speaker Programs for ※Risperdal in Children and
Adolescents with Severe and Disruptive Behaviors and
Below Average IQ§

2002 Business and Tactical Plans for
Pediatric Market
? ※Reach New Heights with Risperdal in 2002§
? 4 key business strategies:
每 Understand level of awareness of Risperdal in children
每 Educate health care providers on therapeutic options for
treatment childhood mental illness
每 Develop a child and adolescent PR and media
management plan

2002 - C & A Business Plan
? RISPERDAL is the most prescribed of the atypical
antipsychotics; however, as is the case with the other
atypicals, RISPERDAL is not currently indicated for use in
children and adolescents. The business plan will focus on
continued market understanding, medical education efforts,
the drug commercialization efforts necessary to capitalize
on the market opportunities for the brand in the child and
adolescent segment.
? J&J has a unique opportunity in the child and adolescent
psychopharmacology marketplace due to its product
offerings across multiple operating companies.

A Building Block for Success
? Promotional materials included
advertisements showing children playing with
blocks and claiming:
? ※potentially prolactin-related adverse events
in patients treated with Risperdal were
comparable to those with placebo.§

2002 J&J Center for Pediatric
Psychopathology at Mass General
Thousands of dollars donated to the Hospital
run by Dr. Joseph Beiderman.
※Mission of the Center is to create common
ground for a strategic collaboration between J&J
and the Pediatric Psychopharmacology
Research Program＃ and move forward the
commercial goals of J&J.§

Biederman later disciplined by
Harvard
? ※Biederman also courted funding from Johnson &
Johnson by promising that his work at Mass. General
would promote the use of its anti-psychotic Risperdal
in children. Johnson & Johnson gave the hospital
$700,000 for a Biederman-led research center that
performed studies promoting Risperdal.§

More Promotions 每 2003 M-Tabs
? District Managers encouraged contests and other
incentives to promote quick dissolving Risperdal for
kids ※there is a very large market for M-Tabs for
children§
? San Antonio 每 Back to School ※bashing§ parties -
encouraged ice cream parties, snacks and lunches
to promote M-Tabs
? Lollipops and Small toys to be included in the kit
with a coupon and a one box sample. Great for
child and adolescent psychiatrists

2003, 2004, 2005, 2006＃＃
2003 每 they submit another application for a child and
adolescent indication.
2004 每 pending
2005 每 ※not approvable§
2006 每 irritability associated with autism
2007 每 mania associated with bipolar and
schizophrenia
NO OTHER C&A INDICATIONS WERE EVER GRANTED

DOJ Action - $2.2Billion
? Risperdal Qui Tam
每 In a separate action brought by the U.S. DOJ, J&J
agreed in November 2013 to pay more than $2.2
billion to federal and state governments and in
penalties to resolve criminal and civil allegations
that the company promoted powerful psychiatric
drugs, including Risperdal, for unapproved uses in
children, seniors and disabled patients. Company
pays $1.273 billion in civil penalties.
http://www.justice.gov/opa/pr/2013/November/
13-ag-1170.html

Philadelphia Litigation

Philadelphia Litigation
? The Honorable Arnold L. New
? Plaintiffs＊ Liaison Counsel
每 Christopher Gomez, Sheller, P.C., Philadelphia, PA
每 Thomas R. Kline, Kline & Specter, Philadelphia, PA
? Defendants＊ Liaison Counsel
每 Kenneth R. Murphy, Drinker Biddle & Reath, LLP, Philadelphia, PA
? 1,300+ Cases Pending

Risperdal Timeline in Philadelphia
? First Complaint Filed in January 2010
? Mass Tort Created in March 2010
? Master Complaint Filed in June 2010
? First Amend Master Complaint Filed in September 2010
? Second Amended Master Complaint Filed in April
2012
? Three Bellwether Trials begin in September/October
2012
? Settlement of filed cases only

Case Management in Philadelphia
? CMO1 每Deadlines, Service, etc.
? CMO3 每PFS, DFS, Authorizations, SFC
? CMO4 - Protective Order
? CMO5 每 Appt. of a Discovery Master
? CMO7 每 Filing of Qualified Trust Motions
? Proposed CMO10- Stay of Cases Affected
By SOL Winter Decision
? http://courts.phila.gov/common-
pleas/trial/civil/clc.asp

Court Grants MSJ 每 No Punitive Damage Recovery

Court Grants MSJ on SOL Motion
? No Discovery Rule tolling of SOL after June 30, 2009.

California Litigation

California Litigation
? The Honorable William Highberger
? Plaintiffs＊ Lead Counsel
每 Robert A. Mosier, Sanders Phillips Grossman, Irvine, CA
每 Daniel S. Robinson, RCRSD, Newport Beach, CA
? Defendants＊ Lead Counsel
每 Steven Selna, Drinker Biddle & Reath, LLP, San
Francisco, CA
? 3,000+ Plaintiffs (batch complaints)

Risperdal Timeline in California
? First Complaint Filed in January 2014
? Mass Tort (JCCP) Created in May 2014
? First Hearing July 2014
? Bellwether Trials set June 2016
? Discovery proceeding
每 Depositions
每 Third Party (Canadian Production)
每 RFP＊s, ROG＊s
每 Clinical Trial electronic data
每 Clinical Trial Master Files
每 CRF＊s
每 Case Specific

Case Management in California
? CMO1 每Lead/Liaison Counsel
? CMO2 每 Plaintiff Steering Committee
? CMO3 - Protective Order
? CMO5 每 PFS/DFS
? CMO6, 7 每 Discovery

St. Louis Litigation

St. Louis Litigation
? First Batch Complaint Remanded May 4, 2015 (64
Plaintiffs) 每 Driscoll Firm, St. Louis
? Defense Counsel
每 Richard P. Cassetta, Stephen Strauss and Stefan Mallen of
Bryan Cave in St. Louis.
? Beginning phases of discovery
? No Trial dates yet

Trials - Philadelphia

Recent Philadelphia Trials
? Pledger Trial began January 2015 (Plaintiff verdict)
? Cirba Trial began February 2015 (Defense verdict)
? Both Pre-2006 label cases
? Failure to warn only
? Tom Kline & Chris Gomez for Plaintiff in both cases
? Diane Sullivan & Ken Murphy for Defense
(Pledger)
? John Winter & William Essig for Defense (Cirba)
? Next two trials to be scheduled for October 2015

57
Defenses

?Puberty
?Other Causes
?Timing
Defenses

? Physiological
? Idiopathic
? Illicit drug usage such as
marijuana
? Drug exposures
? Leydig cell tumor
? Sertoli cell tumor
? Adrenal tumors
? HCG secreting tumors
? Aromatase excess syndrome
(increases the conversion of
testosterone to estrogen)
? Hyperthyroidism
? Hypergonadotropic
Hypogonadism (such as
Klinefelter Syndrome)
? Hypogonadotropic
hypogonadism
? Hyperprolactinemia (only if it
induced hypogonadotropic
hypogonadism)
? Exposure to estrogens (such as
lavender, and tea tree oils)
? Medication exposure
? Klinefelter syndrome
Defenses: Other Causes

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Defenses: Timing
PLEDGER
- Evidence Plaintiff had breast growth while on Risperdal
- Photos
- Mother was a strong witness
- Kessler live
CIRBA
- little evidence Plaintiff had breast growth while on Risperdal
- No Photos
- Mother and son were not strong witnesses
- 5 treating physicians 每 no adverse effects while on drug

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Verdicts
Pledger:
$2.5 Million
Failure to Warn only
No Punitives allowed
Disfigurement
Cirba:
Jury found Janssen Negligent
Jury found no Causation

63
Upcoming Trials
PHILADELPHIA
Trial settings October 2015 and Spring 2016
CALIFORNIA
Trial settings June 2016

Case Criteria

An A Case
? Timeframe of use: minor used between 9/2001
and 10/2006
每 When Janssen should have warned about association
between Risperdal and gynecomastia and did not
? Diagnosis:
每 Mentioned in medical records
每 Must have gynecomastia while ON Risperdal
? Off-label use that remains off-label to date:
每 Anything other than schizophrenia, mania associated
with Bipolar I, and irritability associated with autism

Risperdal Screening Criteria
? Children (2001 to present)
每 Males only
每 Took Risperdal (off-label use preferred)
每 Breast growth while on drug
每 Took Risperdal for at least 30 days (90+ days preferable)
每 Name brand Risperdal
每 The generic brand Patriot - the Patriot generic is an
※authorized generic§ pharmaceutical
? Risperdal became generic in June 30, 2008; however, you will see
brand name prescriptions after this date
? NDC codes - http://www.accessdata.fda.gov/scripts/cder/ndc/
每 Photos of permanent breast growth

Adult Cases
? Considerations:
每 Research findings of older men with increased risk
of gynecomastia in risperidone and paliperidone
(Invega) users compared to nonusers (69%
increased risk)
? Mahyar Etminan, PharmD, et al., Antipsychotic May
Boost Gynecomastia Risk. Medscape. Mar 17, 2014
每 Pre-2008 label = Rare 每 Less than .1%
每 Post-2008 label = Less than 1%

Questions?
Robert A. Mosier
Sanders Phillips Grossman, LLC
2860 Michelle Drive, Ste 220
Irvine, CA 92606
Rmosier@thesandersfirm.com
949-233-7002 Cell

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